MAUDE Adverse Event Report: COVIDIEN 20ML SYR LUER LOCK TIP; SYRINGE, PISTON

Model Number 1182000777

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/26/2020

Event Type  malfunction  

Manufacturer Narrative

The incident sample has been requested but to date has not been received for evaluation. if the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted. as part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.

Event Description

The customer reported that the syringe was leaking during compounding medication.When the clinicians were trying to compound medication in and iv bag using the syringes, there was leakage of medication out of the back of the syringe by the plunger, while the medication was being injected.There was no patient harm reported.

Manufacturer Narrative

Section d4 has been updated to reflect the correct lot number.

Manufacturer Narrative

Additional information: h4 device manufacture date added.H3 evaluation summary: the device history record (dhr) for reported lot was reviewed.During the packaging of this lot, pieces were visually and physically tested with no issues recorded relating to this customer report.The dhr for the lot control indicates that product and specification requirements were met with no non-conforming product identified relating to this customer report.The manufacturing site received 412 packaged samples with this customer report.Visual inspection to the quality inspection standard (qis) was conducted.Two malformed, non-cylindrical syringes were identified.A syringe with an illegible ¿ml¿ print was identified on 5 of the syringes and an illegible ¿monoject¿ print was identified on one of the syringe samples.Smeared print of a numeral was identified on two of the syringes returned.Leak testing was performed on the two non-cylindrical syringes.The leak test is conducted to verify the syringe draws, holds, and expels fluid properly by inserting the syringe into a rubber block for resistance.The syringe would only draw water to the 5 ml mark and when the water was expelled, the water leaked past the rubber tip on both syringe samples.Leak testing was also conducted on a statistical sample size of 50 pieces of the returned samples and all 50 syringes passed the leak testing.The most probable root cause for the confirmed defect of syringe leaking past the rubber stopper/plunger rod is determined to be a result of the non-cylindrical barrels.This condition can be a result of the barrel being pinched or damaged while being transferred in the kahle.The two barrels which failed the leak test performed were confirmed to have entered the dial from two separate barrel rails.Both barrels appear to have been damaged due to either a part being jammed within the dial which then impacted the barrels as they were being transferred or the dials may have been slightly out of alignment.Per procedure, complaint trends are evaluated during the monthly corrective and preventative action (capa) meeting to determine if a capa is warranted.At this time, there is not enough information and a capa will not be initiated.However, these conditions will be communicated to the appropriate manufacturing and quality assurance personnel through a quality alert to heighten awareness.This complaint will be used for tracking and trending purposes.

• Brand Name: 20ML SYR LUER LOCK TIP
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): COVIDIEN; 1222 sherwood rd; norfolk NE 68701
• MDR Report Key: 10740354
• MDR Text Key: 213198555
• Report Number: 1915484-2020-01197
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 10884521010802
• UDI-Public: 10884521010802
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup,Followup
• Report Date: 03/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 1182000777
• Device Catalogue Number: 1182000777
• Device Lot Number: 023727X
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/26/2020
• Initial Date FDA Received: 10/27/2020
• Supplement Dates Manufacturer Received: 10/26/2020; 10/26/2020
• Supplement Dates FDA Received: 11/20/2020; 03/09/2021
• Patient Sequence Number: 1